Merck & Co Stock Price, News & Analysis

Veeva Systems (NYSE: VEEV) announced that Merck (NYSE: MRK) has committed to implementing Veeva Vault CRM to support their upcoming product launches across multiple therapeutic areas. The partnership expansion highlights Merck's strategic decision to leverage Vault CRM for enhanced commercial execution.

Vault CRM, part of the Vault CRM Suite, offers deep applications for commercial execution across personal and digital channels, featuring advanced global capabilities to address region-specific business and compliance requirements. This technology adoption comes at a crucial time as Merck prepares for one of its most significant launch periods in company history.

Merck (NYSE: MRK) has announced the initiation of Phase 3 EXPrESSIVE clinical trials for MK-8527, a groundbreaking once-monthly oral HIV prevention pill. The program includes two major trials: EXPrESSIVE-11, starting in August 2025 across 16 countries, and EXPrESSIVE-10, focusing on women and adolescent girls in sub-Saharan Africa.

The decision follows successful Phase 2 trial results involving 350 participants, which demonstrated favorable safety profiles and pharmacokinetics supporting monthly dosing. The development is backed by the Gates Foundation, addressing a critical need as only 18% of global PrEP needs are currently met, with 1.3 million new HIV cases reported in 2023.

Merck Animal Health (NYSE:MRK) has received FDA approval for BRAVECTO® QUANTUM, a groundbreaking once-yearly injectable parasiticide for dogs. This innovative treatment provides 12-month protection against fleas and ticks through a single injection, making it the longest-acting systemic product in the market.

The product, already approved in over 50 countries including Australia, New Zealand, and the EU, will be available in U.S. veterinary clinics by August 2025. BRAVECTO QUANTUM is approved for dogs and puppies 6 months and older, providing protection against multiple tick species including black-legged, American dog, and brown dog ticks for 12 months, and lone star ticks for 8 months.

Merck (NYSE: MRK) announced that the FDA has accepted its New Drug Application (NDA) for doravirine/islatravir (DOR/ISL), a novel once-daily, oral, two-drug regimen for adults with virologically suppressed HIV-1 infection. The FDA has set a PDUFA target date of April 28, 2026.

The application is supported by Week 48 data from two Phase 3 trials (MK-8591A-051 and MK-8591A-052) where DOR/ISL demonstrated non-inferior efficacy to baseline antiretroviral therapy and BIC/FTC/TAF, with a generally comparable safety profile. If approved, DOR/ISL would become the first FDA-approved two-drug regimen without an integrase inhibitor for HIV treatment.

Merck (NYSE: MRK) has announced a definitive agreement to acquire Verona Pharma (Nasdaq: VRNA) for $107 per ADS, representing a total transaction value of approximately $10 billion. The acquisition's centerpiece is Ohtuvayre® (ensifentrine), a first-in-class COPD maintenance treatment that received FDA approval in June 2024.

Ohtuvayre is the first novel inhaled mechanism for COPD treatment in over 20 years, combining bronchodilator and non-steroidal anti-inflammatory effects. The drug, launched in August 2024, has shown rapid market uptake and is also being evaluated for non-cystic fibrosis bronchiectasis.

The transaction, unanimously approved by both boards, is expected to close in Q4 2025, subject to regulatory approvals and customary conditions. The acquisition aligns with Merck's science-led business development strategy and aims to expand its cardio-pulmonary portfolio.

Merck (NYSE: MRK) will present new data from its HIV prevention and treatment pipeline at the 13th International AIDS Society Conference (IAS 2025) in Kigali, Rwanda, from July 13-17, 2025. Key highlights include:

The company will share Phase 2 data on MK-8527, a novel once-monthly oral HIV prevention drug, and results from three Phase 3 trials examining doravirine/islatravir's effectiveness against resistance mutations. Additionally, data will be presented on a once-weekly oral combination of islatravir and ulonivirine (ISL/ULO) for HIV-1 treatment.

Based on Phase 1 and Phase 2b trial results, Merck is advancing the development of MK-8591B, a weekly oral combination of islatravir (2mg) and ulonivirine (200mg). The company will also host a virtual investor event on July 17, 2025, to discuss their advancing HIV research pipeline.

Merck (NYSE:MRK) announced that the FDA has granted priority review for WINREVAIR's supplemental Biologics License Application (sBLA). The review aims to update the product label based on the Phase 3 ZENITH trial results, with a PDUFA date set for October 25, 2025.

The ZENITH trial demonstrated remarkable efficacy, showing a 76% reduction in the risk of composite events including death, lung transplantation, and PAH hospitalization compared to placebo. The trial was notably stopped early due to overwhelming efficacy, marking the first PAH Phase 3 outcome study focused entirely on major morbidity and mortality events.

WINREVAIR, currently approved in over 45 countries, is used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity, WHO functional class, and reduce clinical worsening events.

Merck (NYSE: MRK) has scheduled its second-quarter 2025 sales and earnings conference call for Tuesday, July 29, at 9:00 a.m. ET. During the call, company executives will present an overview of Merck's Q2 2025 performance to institutional investors and analysts.

The call will be accessible through a live audio webcast, with dial-in options available for participants at (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 using access code 9818590. Following the call, a replay of the webcast, sales and earnings release, supplemental financial disclosures, and presentation slides will be made available on Merck's website.

Merck (NYSE: MRK) announced that the CDC's Advisory Committee on Immunization Practices (ACIP) has recommended ENFLONSIA™ for preventing RSV lower respiratory tract disease in infants under 8 months of age. ENFLONSIA, recently FDA-approved, is the first and only RSV preventive option using the same dose regardless of infant weight.

The preventive monoclonal antibody provides protection through 5 months, covering a typical RSV season. Notably, ENFLONSIA has been included in the Vaccines for Children Program, enhancing accessibility. Merck plans to begin taking orders in July 2025, with deliveries scheduled before the 2025-2026 RSV season.